Puma Biotechnology to Host Conference Call to Discuss Fourth Quarter and Full Year Financial Results

On February 15, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, March 1, 2018 following release of its fourth quarter and full year 2017 financial results (Press release, Puma Biotechnology, FEB 15, 2018, http://investor.pumabiotechnology.com/press-release/puma-biotechnology-host-conference-call-discuss-fourth-quarter-and-full-year-financial [SID1234524014]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

Portola Pharmaceuticals to Announce Fourth Quarter and Full Year 2017 Financial Results and Host Conference Call on Wednesday, February 28, 2018

On February 15, 2018 Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) reported that it will host a webcast and conference call to discuss the Company’s financial results for the fourth quarter and full year ended December 31, 2017, and provide a general business overview on Wednesday, February 28, 2018, at 4:30 p.m. ET (1:30 p.m. PT) (Press release, Portola Pharmaceuticals, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332869 [SID1234524013]).

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Conference Call Details
The live conference call on Wednesday, February 28, 2018, at 4:30 p.m. ET, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 4893459. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

Health Canada Approves New Indication for ZYTIGA®* (abiraterone acetate), Broadening its Use for Treatment of Newly Diagnosed Metastatic Prostate Cancer

On February 15, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported Health Canada’s approval of ZYTIGA (abiraterone acetate) in combination with prednisone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer (mHSPC) who may have received up to three months of prior ADT (Press release, Johnson & Johnson, FEB 15, 2018, View Source [SID1234524007]).

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This latest approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, a multinational, multicenter, randomized, double-blind, placebo-controlled trial (N=1,199) that examined the use of ZYTIGA 1,000 mg once daily in combination with prednisone 5 mg once daily and ADT, compared to placebos plus ADT in patients with newly diagnosed mHSPC.3 The study showed ZYTIGA, in combination with prednisone and ADT reduced the risk of death by 38 per cent compared to placebo plus ADT (median OS not reached vs. 34.7 months, respectively; HR=0.62; 95% confidence interval [CI], 0.51 to 0.76; P < 0.001) in patients with mHSPC.4

"Previously men with newly diagnosed metastatic prostate cancer have had limited options for first-line treatments," Dr. Fred Saad, Chief of Urology, Centre Hospitalier de l’Université de Montréal, Université de Montreal and LATITUDE clinical investigator.** "This latest approval for ZYTIGA is an exciting milestone for men, their caregivers and treating clinicians as it provides a new first-line treatment option for high-risk metastatic hormone-sensitive prostate cancer that improves overall survival and quality of life."

About the LATITUDE Study
The LATITUDE study, published in the New England Journal of Medicine,5 enrolled 1,199 newly diagnosed patients with high-risk mHSPC and was conducted at 235 sites in 34 countries, including sites in 10 Canadian cities and with 33 Canadian patients.6,7 A total of 597 patients were randomized within three months of diagnosis to receive ADT plus ZYTIGA and prednisone, while 602 patients were randomized to receive ADT and placebo.8 Patients were high-risk mHSPC as defined as having at least two of the three following factors associated with poor prognosis: Gleason score ≥8, ≥3 bone lesions and/or presence of measurable visceral metastases.9

Overall, the safety profile of ZYTIGA in combination with prednisone and ADT was similar to prior studies in patients with metastatic castration-resistant prostate cancer (mCRPC).10 In the LATITUDE study, patients received a lower dose of prednisone at 5 mg/day with the usual dose of ZYTIGA at 1,000 mg/day plus ADT. The most common all grade adverse reactions (≥10%) observed with ZYTIGA compared to placebo were hypertension (36.7% versus 22.1%), hypokalemia (20.4% versus 3.7%) and hot flushes (15.4% versus 12.5%).

About Prostate Cancer in Canada
Prostate cancer is a disease where prostate cells lose control of growth and division, and are no longer able to function as healthy cells.11,12 It can be slow-growing and go undetected for years.13

Prostate cancer is the most common cancer among Canadian men, with approximately 21,300 men diagnosed each year.14 Roughly 10 to 20 per cent of those living with prostate cancer will present with metastatic disease,15 in which the tumour has spread beyond the prostate to other parts of the body. There is no cure for metastatic prostate cancer.16

Metastatic hormone-sensitive prostate cancer refers to prostate cancer that still responds to testosterone suppression therapy.17 Patients with newly diagnosed metastatic disease and high-risk disease characteristics tend to have a poorer prognosis.18

About ZYTIGA
ZYTIGA blocks CYP17-mediated androgen production at three sources: in the testes, adrenals and the prostate tumour tissue.19 Androgen production left unchecked fuels the growth of prostate cancer.20

Health Canada first approved ZYTIGA in 2011 to be used in combination with prednisone for the treatment of mCRPC in patients who have received prior chemotherapy containing docetaxel after failure of ADT. In 2013, it was approved for mCRPC in patients who are asymptomatic or mildly symptomatic after failure of ADT.21

Insmed to Host Fourth Quarter and Full Year 2017 Financial Results Conference Call on Friday, February 23, 2018

On February 15, 2018 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that it will release its fourth quarter and year-end financial results on Friday, February 23, 2018 (Press release, Insmed, FEB 15, 2018, View Source [SID1234524006]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Friday, February 23, 2018 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (844) 707-0669 (domestic) or (703) 639-1223 (international) and referencing conference ID number 9066979. The call will also be webcast live on the internet on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately two hours after its completion through March 2, 2018 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and referencing conference ID number 9066979. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

Incyte Reports 2017 Fourth-Quarter and Year-End Financial Results, Provides 2018 Financial Guidance and Updates on Key Clinical Programs

On February 15, 2018 Incyte Corporation (Nasdaq: INCY) reported its 2017 fourth-quarter and year-end financial results, highlighting both strong growth in total revenue and the significant progress being made across the product portfolio (Press release, Incyte, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332680 [SID1234524005]).

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"2017 was another successful year for Incyte with a fast-growing revenue line and an expanded portfolio of later-stage development candidates that we expect to drive our future growth," stated Hervé Hoppenot, Incyte’s Chief Executive Officer. "As we begin 2018, we look forward to key newsflow events in the first half of the year, including the initial results of the ECHO-301 trial of epacadostat in melanoma and the REACH1 trial of ruxolitinib in steroid-refractory acute GVHD, as well as FDA action on the resubmission of the baricitinib NDA for rheumatoid arthritis."

Portfolio Update

Oncology – key highlights

The pivotal REACH1 trial evaluating ruxolitinib in patients with steroid-refractory acute graft-versus-host disease (GVHD) has completed enrollment and results are expected in the first half of 2018. If successful, Incyte expects to submit an sNDA seeking approval of ruxolitinib in this indication.

Initial results, based on progression-free survival, from the pivotal ECHO-301 trial of epacadostat plus pembrolizumab in patients with unresectable or metastatic melanoma are expected in the first half of 2018. In collaboration with both Merck and Bristol-Myers Squibb, we have recently opened eight new pivotal trials of epacadostat plus PD-1 antagonists.

Initial data from the trial evaluating INCB54828 in patients with cholangiocarcinoma are expected in 2018.

Status updates for Incyte’s most advanced clinical programs are provided below.


Indication Status Update
Ruxolitinib
(JAK1/JAK2)

Steroid-refractory acute GVHD Pivotal Phase 2 (REACH1); Phase 3 (REACH2)
Ruxolitinib
(JAK1/JAK2)

Steroid-refractory chronic GVHD Phase 3 (REACH3)
Ruxolitinib
(JAK1/JAK2)

Essential thrombocythemia Phase 2 (RESET)
Itacitinib
(JAK1)

Treatment-naïve acute GVHD Phase 3 (GRAVITAS-301)
Itacitinib
(JAK1)

NSCLC Phase 1/2 in combination with osimertinib (EGFR)
Epacadostat
(IDO1)

Melanoma Phase 3 (ECHO-301) in combination with pembrolizumab (PD-1)
Epacadostat
(IDO1)

Renal cancer Phase 3 (ECHO-302) in combination with pembrolizumab (PD-1)
Epacadostat
(IDO1)

Bladder cancer Phase 3 (ECHO-303 & ECHO-307) in combination with pembrolizumab (PD-1)
Epacadostat
(IDO1)

Head & neck cancer Phase 3 (ECHO-304) in combination with pembrolizumab (PD-1)
Epacadostat
(IDO1)

NSCLC Phase 3 (ECHO-305 & ECHO-306) in combination with pembrolizumab (PD-1)
Epacadostat
(IDO1)

NSCLC
Phase 3 (ECHO-309) in combination with nivolumab (PD-1)

Epacadostat
(IDO1)

Head & neck cancer
Phase 3 (ECHO-310) in combination with nivolumab (PD-1)

Epacadostat
(IDO1)

NSCLC Phase 3 in combination with durvalumab (PD-L1) expected to begin in H1 2018
MGA012
(PD-1)1

Solid tumors Phase 1 dose-escalation completed, monotherapy expansion cohorts ongoing
INCB50465
(PI3Kδ)

DLBCL Phase 2 (CITADEL-202)
INCB50465
(PI3Kδ)

Follicular lymphoma Phase 2 (CITADEL-203)
INCB50465
(PI3Kδ)

Marginal zone lymphoma Phase 2 (CITADEL-204)
INCB50465
(PI3Kδ)

Mantle cell lymphoma Phase 2 (CITADEL-205)
INCB54828
(FGFR1/2/3)

Bladder cancer Phase 2 (FIGHT-201)
INCB54828
(FGFR1/2/3)

Cholangiocarcinoma Phase 2 (FIGHT-202)

Notes:
1) MGA012 licensed from MacroGenics

A brief status update for Incyte’s earlier-stage clinical candidates is provided below.


Status Update
INCB57643
(BRD)

First-in-man data presented at ASH (Free ASH Whitepaper) 2017, showing optimized PK profile for combination therapy
INCB53914
(PIM)

First-in-man data at ASH (Free ASH Whitepaper) 2017; development expected to focus on combination therapy, including with JAK and PI3Kδ inhibition in hematological malignancies
INCB52793
(JAK1)

150x greater selectivity for JAK1 over JAK2 in preclinical studies; evaluating combination cohorts with azacitadine in AML
INCB59872
(LSD1)

Epigenetic mechanism targeting cell differentiation; evaluating both oncology indications and sickle-cell disease
INCB62079
(FGFR4)

250x greater selectivity for FGFR4 over FGFR1/2/3; initial development expected to focus on hepatocellular carcinoma
INCB81776
(AXL/MER)

Expected to enter clinical trials in 2018
INCB01158
(ARG)1

Novel mechanism targeting myeloid cells; development expected to focus on combination therapy, including IDO1, PD-1 and chemotherapy combinations
INCAGN1876
(GITR)2

Dose escalation completed; development expected to focus on combination therapy, including IDO1, PD-1 and CTLA-4 combinations
INCAGN1949
(OX40)2

Dose escalation completed; development expected to focus on combination therapy, including PD-1 and CTLA-4 combinations
INCAGN2390
(TIM-3)2

Expected to enter clinical trials in 2018
INCAGN2385
(LAG-3)2

Expected to enter clinical trials in 2018

Notes:
1) INCB01158 co-developed with Calithera
2) INCAGN1876, INCAGN1949, INCAGN2390 and INCAGN2385 from discovery alliance with Agenus

Non-oncology


Indication Status Update
Topical ruxolitinib
(JAK1/JAK2)

Atopic dermatitis, vitiligo Phase 2

Partnered – key highlights

In December, Lilly announced that it had resubmitted the New Drug Application (NDA) for baricitinib to the U.S. Food & Drug Administration (FDA). This was classified as a Class II resubmission, which began a new six-month review cycle. Lilly also announced that it has initiated a pivotal trial of baricitinib in patients with moderate-to-severe atopic dermatitis.

Novartis has stated that it now anticipates submitting an NDA for capmatinib, a potent and selective MET inhibitor licensed from Incyte, in 2019.


Indication Status Update
Baricitinib (JAK1/JAK2)1 Rheumatoid arthritis Approved in Europe and Japan; NDA resubmitted to FDA
Baricitinib (JAK1/JAK2)1 Atopic dermatitis Phase 3
Baricitinib (JAK1/JAK2)1 Psoriatic arthritis Lilly expects the Phase 3 program to begin in 2018
Baricitinib (JAK1/JAK2)1 Systemic lupus erythematosus Phase 2
Capmatinib (MET)2 Non-small cell lung cancer, liver cancer Phase 2 in EGFR wild-type, ALK negative NSCLC patients with MET amplification and mutation

Notes:
1) Baricitinib licensed to Lilly
2) Capmatinib licensed to Novartis

2017 Fourth-Quarter and Year-End Financial Results (GAAP)

Revenues For the quarter ended December 31, 2017, net product revenues of Jakafi were $302 million as compared to $238 million for the same period in 2016, representing 27 percent growth. For the twelve months ended December 31, 2017, net product revenues of Jakafi were $1.1 billion as compared to $853 million for the same period in 2016, representing 33 percent growth. For the quarter ended December 31, 2017, net product revenues of Iclusig were $19 million as compared to $13 million for the same period in 2016. For the twelve months ended December 31, 2017, net product revenues of Iclusig were $67 million as compared to $30 million for the same period in 20161.

For the quarter and twelve months ended December 31, 2017, product royalties from sales of Jakavi, which has been out-licensed to Novartis outside of the United States, were $48 million and $152 million, respectively, as compared to $33 million and $111 million for the same periods in 2016. For the quarter and twelve months ended December 31, 2017, product royalties from sales of Olumiant outside of the United States from Lilly were $5 million and $9 million, respectively.

For the quarter and twelve months ended December 31, 2017, milestone and contract revenues were $70 million and $175 million, respectively, as compared to $43 million and $113 million for the same periods in 2016. The milestone and contract revenues in 2017 relate to milestones earned from our collaborative partners.

For the quarter ended December 31, 2017, total revenues were $444 million as compared to $326 million for the same period in 2016. For the twelve months ended December 31, 2017, total revenues were $1.5 billion as compared to $1.1 billion for the same period in 2016.

1 In June 2016, Incyte obtained an exclusive license from ARIAD to develop and commercialize Iclusig in Europe and other select ex-U.S. countries.

Research and development expenses Research and development expenses for the quarter ended December 31, 2017 were $447 million as compared to $162 million for the same period in 2016. For the quarter ended December 31, 2017, research and development expenses were comprised of $150 million related to our collaboration and license agreement with MacroGenics and $297 million of ongoing expenses.

Research and development expenses for the twelve months ended December 31, 2017 were $1.3 billion as compared to $582 million for the same period in 2016. For the twelve months ended December 31, 2017, research and development expenses were comprised of $359 million of upfront consideration and milestone expense related to our collaboration and license agreements with Agenus, Calithera, MacroGenics and Merus, $12 million related to in-process research and development asset impairment and $955 million of ongoing expenses.

Included in ongoing research and development expenses for the quarter and twelve months ended December 31, 2017 were non-cash expenses related to equity awards to our employees of $23 million and $90 million, respectively.

Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and twelve months ended December 31, 2017 were $98 million and $366 million, respectively, as compared to $96 million and $303 million for the same periods in 2016. Increased selling, general and administrative expenses were driven primarily by additional costs related to the commercialization of Jakafi and the geographic expansion in Europe. Included in selling, general and administrative expenses for the quarter and twelve months ended December 31, 2017 were non-cash expenses related to equity awards to our employees of $11 million and $43 million, respectively.

Change in fair value of acquisition-related contingent consideration The change in fair value of acquisition-related contingent consideration for the quarter and twelve months ended December 31, 2017 was $10 million and $8 million, respectively, as compared to $7 million and $17 million for the same periods in 2016. The change in fair value of acquisition-related contingent consideration represents the fair market value adjustments of the Company’s contingent liability related to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.

Unrealized loss on long term investments Unrealized loss on long term investments for the quarter ended December 31, 2017 was $22 million as compared to $24 million for the same period in 2016. The unrealized loss on long term investments for the twelve months ended December 31, 2017 was $24 million as compared to $3 million for the same period in 2016. The unrealized loss on long term investments for the quarter and twelve months ended December 31, 2017 represents the fair market value adjustments of the Company’s investments in Agenus and Merus.

Expense related to senior note conversions Expense related to senior note conversions for the twelve months ended December 31, 2017 was $55 million related to the conversions of certain of our 2018 and 2020 convertible senior notes.

Net income (loss) Net loss for the quarter ended December 31, 2017 was $150 million, or $0.71 per basic and diluted share, as compared to net income of $9 million, or $0.05 per basic and diluted share for the same period in 2016. Net loss for the twelve months ended December 31, 2017 was $313 million, or $1.53 per basic and diluted share, as compared to net income of $104 million, or $0.55 per basic and $0.54 per diluted share for the same period in 2016.

As described below, in 2018 Incyte will begin reporting certain Non-GAAP financial measures, which should be considered in conjunction with Incyte’s GAAP reporting. Under Incyte’s definition of Non-GAAP measures, Non-GAAP net income for the quarter and twelve months ended December 31, 2017 was $4 million and $131 million, respectively.

Cash, cash equivalents and marketable securities position As of December 31, 2017, cash, cash equivalents and marketable securities totaled $1.2 billion as compared to $809 million as of December 31, 2016. The increase in cash, cash equivalents and marketable securities from December 31, 2016 to December 31, 2017 is primarily due to the public offering of 4,945,000 shares of our common stock resulting in net proceeds of $649 million.

Non-GAAP Information

The financial measures other than Non-GAAP net income presented in this press release for the three and twelve months ended December 31, 2017 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). Management has chosen to present Non-GAAP net income for the three and twelve months ended December 31, 2017 and to release both GAAP and Non-GAAP financial guidance for the year ending December 31, 2018 in belief that this Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP financial guidance. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for both revenues and expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. A reconciliation of GAAP net loss to Non-GAAP net income for the three and twelve months ended December 31, 2017 has been included at the end of this press release.

Guidance related to research and development and selling, general and administrative expenses does not include estimates associated with any potential future strategic transactions.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

Conference Call and Webcast Information

Incyte will hold its 2017 fourth-quarter and year-end financial results conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13675376.

If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13675376.

The conference call will also be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations".